Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Primary Purpose
Cholecystolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Madany Closure
Standard closure
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystolithiasis
Eligibility Criteria
Inclusion Criteria: age . 18 years eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate
Sites / Locations
- Aswan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Madany closure
Control
Arm Description
the novel port site closure technique is to be done for this group
external closure of the port site
Outcomes
Primary Outcome Measures
closure time
closure time in seconds
rate of closure failure
rate failure to close the port site
Secondary Outcome Measures
incidence of port site infection
incidence of infection of the port site
incidence of port site hernia
incidence of hernia at the port site
Full Information
NCT ID
NCT06035302
First Posted
September 6, 2023
Last Updated
September 17, 2023
Sponsor
ClinAmygate
Collaborators
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06035302
Brief Title
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Official Title
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
this study aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Madany closure
Arm Type
Experimental
Arm Description
the novel port site closure technique is to be done for this group
Arm Title
Control
Arm Type
Active Comparator
Arm Description
external closure of the port site
Intervention Type
Procedure
Intervention Name(s)
Madany Closure
Intervention Description
Madany Closure is a new technique for the porte site closure
Intervention Type
Procedure
Intervention Name(s)
Standard closure
Intervention Description
Standard closure technique of the port site from ecternal
Primary Outcome Measure Information:
Title
closure time
Description
closure time in seconds
Time Frame
1 day
Title
rate of closure failure
Description
rate failure to close the port site
Time Frame
1 day
Secondary Outcome Measure Information:
Title
incidence of port site infection
Description
incidence of infection of the port site
Time Frame
1 month
Title
incidence of port site hernia
Description
incidence of hernia at the port site
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age . 18 years
eligible for Laparoscopic cholecystectomy
Exclusion Criteria:
refused to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohie El-Din M Madani, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Emad R Issak, MSc
Phone
01066208065
Email
emangate@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madani, MD
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD
12. IPD Sharing Statement
Learn more about this trial
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
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